Insights On Quality Assurance

  1. Validation Of A Sterilization Process: Part 1 9/9/2025

    Gain essential insights into sterilization by exploring microbial inactivation kinetics, bacterial spore resistance, and key terminology—critical knowledge for ensuring product safety and compliance.

  2. Reduce Batch Failure Risk With An Innovative Platform 6/11/2025

    Enhance reliability in cell therapy manufacturing with an innovative platform. Discover how the closed system and automation reduce operator errors through smart monitoring, pre-checks, alarms, and detailed batch reporting.

  3. Enhancing Ethylene Oxide Sterilization Processes 8/15/2025

    PCDs are patented devices designed to meet the demands of EO sterilization. Gain insight into how they support process development, validation, and monitoring with reliable, reproducible performance.

  4. 4 Conversations To Drive Your Business Case For Digital Validation 3/19/2025

    Change in life sciences is challenging due to strict regulations, high stakes, and the importance of patient safety. Learn how to advocate for digital validation workflows through four key conversations.

  5. Enhancing Viral Vector Sterile Filtration: Process Efficiency And GMP Alignment 11/4/2025

    Explore filtration strategies that improve viral vector yield and quality, with insights on AAV and lentivirus workflows, plus practical guidance for implementing PUPSIT in line with requirements.

  6. ICH Guidelines: Challenges And Solutions For Pharma Manufacturers 10/8/2024

    Take the next step in enhancing your pharmaceutical manufacturing processes by investing in a robust quality management system (QMS) designed for ICH compliance and operational excellence.

  7. Developing Your Risk-Based Approach To Single-Use System Integrity 10/29/2025

    Explore how a holistic approach to single-use system integrity can strengthen contamination control, improve operational efficiency, and meet evolving regulatory expectations in manufacturing.

  8. Takeda's Global Validation Transformation 9/9/2025

    Discover how Takeda transformed its validation process by replacing paper-based workflows with a digital solution to boost efficiency, compliance, and data integrity.

  9. Your Global Partner In Pharmaceutical Contamination Control 6/24/2025

    Ensure cleanroom compliance with an expert team that helps you interpret critical data, align with global regulations, and maintain control through proactive contamination strategies.

  10. Scientific Insights Into VHP Biodecontamination And BI Quality Management 9/24/2025

    VHP biodecontamination ensures aseptic manufacturing, but BI variability challenges validation. Addressing rogue BIs and regulatory shifts strengthens contamination control and process reliability.